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Tag: FDA

  • FDA Tobacco Chief Highlights Progress, Challenges in Product Reviews and Enforcement

    FDA Tobacco Chief Highlights Progress, Challenges in Product Reviews and Enforcement

    Dr. Bret Koplow, acting director of the FDA’s Center for Tobacco Products (CTP), sat down for a fireside chat to kick off the second day of the American Tobacco and Nicotine Forum (ATNF) in Leesburg, Va. Christopher Greer, president and CEO of the Nicotine Resource Consortium, led the discussion on behalf of industry leaders eager to hear more about the inner workings of the regulatory agency.

    Koplow said the agency has made significant progress in reducing its backlog of premarket tobacco applications, cutting it by roughly 70% over the past year and eliminating the acceptance queue. He noted that while the FDA has reviewed approximately 27 million applications, only a small number have been authorized, largely because most submissions lacked the scientific data required to demonstrate public health benefits.

    Koplow said the agency is working to improve transparency and guidance for applicants, including plans to share lessons learned from the review process to help companies better meet regulatory standards. He also pointed to efforts to streamline evaluations in certain product categories, such as nicotine pouches, where a pilot program enabled faster authorizations and is expected to inform broader regulatory approaches.

    On enforcement, Koplow highlighted increased action against illicit products, including major seizures of unauthorized e-cigarettes in coordination with federal agencies, with most originating from China. He acknowledged ongoing challenges in balancing harm reduction for adult smokers with youth protection, noting declines in youth vaping but continued concerns about public understanding of nicotine risks and the need for stronger evidence on comparative benefits of alternative products.

  • Articles Accuse Makary of Putting Reputation Over Science

    Articles Accuse Makary of Putting Reputation Over Science

    Over the weekend, multiple sources criticized FDA Commissioner Marty Makary for being influenced by reputational considerations rather than evolving evidence on risk and consumer behavior in the regulation of reduced-harm nicotine products. According to The Wall Street Journal, tensions have emerged between the White House and the FDA, with the administration pushing to expand access to flavored vaping products while Makary has blocked authorizations despite internal scientific support. The report cited a case involving vape company Glas, where FDA scientists recommended approval of several flavors, but a memo from Makary’s office delayed the decision, highlighting a divergence between scientific review and agency leadership.

    Separately, Brownstone Institute published an article by Roger Bate arguing that regulatory progress on reduced-risk nicotine products has stalled despite declining youth vaping rates and evidence supporting harm reduction. Bate wrote that approvals for products such as vapes and nicotine pouches have slowed significantly, and wrote that “reputable sources” attributed this in part to Makary’s reluctance to act, citing concerns within the agency that decisions are being shaped by reputational risk rather than scientific data.

  • FDA Renews Modified Status for IQOS Products

    FDA Renews Modified Status for IQOS Products

    The U.S. Food and Drug Administration has renewed modified risk tobacco product (MRTP) orders for several Philip Morris International IQOS devices and HeatSticks consumables, allowing the company to continue marketing the products with reduced-exposure claims. The authorization covers two IQOS device systems and three HeatStick variants, with the FDA reaffirming that available scientific evidence supports claims that switching completely from cigarettes to IQOS can significantly reduce exposure to harmful chemicals.

    The products receiving modified risk granted orders are IQOS 2.4 system, IQOS 3.0 system, Marlboro Amber HeatSticks (previously Marlboro HeatSticks), Marlboro Green Menthol HeatSticks (previously Marlboro Smooth Menthol HeatSticks), and Marlboro Blue Menthol HeatSticks (previously Marlboro Fresh Menthol HeatSticks).

    The agency said its latest review found new data consistent with earlier findings from initial approvals granted between 2019 and 2022. Under the renewed orders, Philip Morris can state that the IQOS system heats rather than burns tobacco, resulting in lower production of harmful substances. However, the FDA emphasized that the designation does not mean the products are safe or approved, and it restricts the company from making broader health or risk-reduction claims beyond those explicitly authorized.

    The renewed MRTP status is subject to ongoing regulatory oversight, including requirements for postmarket surveillance to monitor consumer behavior and public health impact. The FDA retains the authority to withdraw the authorization if the products no longer demonstrate a net benefit to population health.

  • FDA Releases Wave 8 PATH Study Data

    FDA Releases Wave 8 PATH Study Data

    New Wave 8 Restricted-Use Files from the Population Assessment of Tobacco and Health (PATH) Study are now available from FDA’s Center for Tobacco Products and NIH’s National Institute on Drug Abuse. The PATH Study is a household-based, nationally representative, longitudinal study of adults and youth (12-17 years old) in the United States. The study was launched in 2011 to inform FDA’s regulatory activities under the Family Smoking Prevention and Tobacco Control Act.

    These Wave 8 files contain data collected between January 2024 and December 2024, including questionnaire data, location characteristics data, and state identifier data. The PATH Study Restricted-Use Files have been updated to include tobacco product Universal Product Code data and Ever/Never reference data for all participants with updated Master Linkage Files. Researchers are encouraged to submit a request to obtain access.

    In addition to these newly released data files, researchers may also request access to all currently available Biomarker Restricted-Use Files. Data and documentation from the Public-Use Files are also available for download with updated Master Linkage Files.

    Questions about the collection, content, weighting, documentation, or structure of PATH Study data may be submitted to PATHDataUserQuestions@Westat.com.

  • Judge Issues Final Ruling on Decade-Long ‘Premium Cigar’ Definition

    Judge Issues Final Ruling on Decade-Long ‘Premium Cigar’ Definition

    A U.S. federal court in Washington, D.C., issued what is said was “hopefully” a final ruling, vacating the FDA’s 2016 Deeming Rule as it applies to premium cigars, marking the conclusion of a decade-long legal battle over the agency’s authority. Judge Amit P. Mehta reaffirmed that premium cigars — defined by criteria such as being handmade, composed of natural tobacco, and free from characterizing flavors — should be treated as a distinct category and excluded from the broader regulatory framework applied to other tobacco products. The decision follows earlier rulings in 2023 and subsequent appellate review, which required the court to revisit and finalize the definition of “premium cigars.”

    The court ultimately upheld its original eight-point definition, rejecting industry proposals to loosen certain requirements and agreeing with the FDA that any refinements should be addressed through formal rulemaking rather than judicial changes. The ruling provides regulatory clarity and removes premium cigars from key FDA oversight requirements, while leaving open the possibility of future changes through the agency’s policymaking process.

    Industry groups welcomed the outcome as a major victory. The Cigar Rights of America (CRA) said the ruling confirms long-standing arguments that premium cigars differ fundamentally from mass-market tobacco products, with Executive Director Mike Copperman calling it “long-overdue clarity” after years of advocacy. Similarly, the Premium Cigar Association (PCA) said the decision brings needed certainty for manufacturers, retailers, and consumers, with CEO Joshua Habursky emphasizing that the outcome recognizes premium cigars as a distinct category warranting separate regulatory treatment.

    The Cigar Association of America (CAA), which previously opposed parts of the ruling not because it disagreed with the exemption itself but because it sought a broader and more flexible definition of what qualifies as a “premium cigar,” did not return a request for comment.

  • PM Urges Court to Uphold FDA Graphic Rule Ruling  

    PM Urges Court to Uphold FDA Graphic Rule Ruling  

    Philip Morris USA asked the U.S. Court of Appeals for the Eleventh Circuit to affirm a lower court decision vacating a U.S. Food and Drug Administration rule that would have required graphic health warnings on cigarette packaging. The company argued that the district court correctly found the FDA failed to follow required administrative procedures when developing the rule. According to Law 360, the appeal centers on whether the agency’s rulemaking process complied with federal standards, after the district court struck down the regulation on procedural grounds.

  • IKE Tech Engages FDA on AI-Powered ENDS Compliance Solutions

    IKE Tech Engages FDA on AI-Powered ENDS Compliance Solutions

    Today (April 9), IKE Tech LLC participated in a formal listening session with the FDA’s Center for Tobacco Products. The company, a joint venture between Ispire Technology Inc., Berify, and Chemular Inc., presented its point-of-use compliance technology, including its patented Human Identity Token (HIT) that prevents youth access to ENDS products, and highlighted the need for a regulatory framework recognizing software as a tobacco product.

    The session focused on enforcement challenges in the ENDS market, including underage access and the spread of illicit products. IKE Tech outlined its technology platform, which integrates biometric age-gating, blockchain-based product authentication, and an AI-powered governance backend. Executives emphasized that these point-of-use systems address compliance gaps that traditional point-of-sale measures cannot.

    IKE Tech also argued that software embedded in or governing a tobacco product should be regulated under the Tobacco Control Act, noting that current PMTA frameworks do not account for continuous updates and lifecycle management of software. The engagement follows FDA guidance identifying Device Access Restrictions as critical for public health determinations, and builds on IKE Tech’s first standalone PMTA for an interoperable, blockchain-based, point-of-use age-gating solution, which demonstrated 100% effectiveness in preventing underage device activation in human factors studies.

  • FDA Wins Default Judgment Against NC Vape Distributor

    FDA Wins Default Judgment Against NC Vape Distributor

    A federal judge granted the U.S. Food and Drug Administration a default judgment against a North Carolina vape distributor accused of importing and selling unauthorized flavored e-cigarettes from China. The ruling allows the FDA to seek a judgment permanently barring the company from importing, marketing, or distributing the products cited in the complaint after the defendant failed to respond to the lawsuit.

    Because the defendants did not appear, they are not publicly posted in the docket entries. However, in September 2025, the FDA filed a complaint against North Carolina-based distributor Dream Distro LLC and its owner, Faisal A. Alhadrami.  

  • FDA Sends ENDS Comment Period Reminder

    FDA Sends ENDS Comment Period Reminder

    Today (April 8), the U.S. Food and Drug Administration’s Center for Tobacco Products issued a reminder that the public has until 11:59 p.m. EDT on May 11 to submit comments on its draft guidance for flavored e-cigarette applications, docketed as FDA-2026-D-1817 on Regulations.gov.

    The reminder relates to draft guidance the agency released on March 11, titled “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk,” which outlines how the FDA plans to weigh the youth appeal of flavored products against any added benefit they may provide to adults compared with tobacco-flavored options, including expectations for evidence on adult switching, youth initiation risk, and the potential use of device access-restriction technology.

  • ‘Made in America’ Claims Rise as Brands Navigate Crackdown

    ‘Made in America’ Claims Rise as Brands Navigate Crackdown

    A Reuters investigation reports a growing wave of vape brands promoting “Made in America” credentials as the U.S. market faces tougher enforcement against unlicensed products, particularly those linked to Chinese manufacturers. The article says at least eight new brands have emerged since October, emphasizing U.S. identity, despite lacking authorization from the U.S. Food and Drug Administration, which has approved only a limited number of vaping products for sale.

    According to the report, trademark filings show some of these brands are tied to Chinese or Hong Kong interests, suggesting the marketing shift may be aimed at avoiding scrutiny from customs officials amid heightened trade tensions and regulatory pressure under the administration of Donald Trump. Analysts cited by Reuters say the tactic could slow efforts to push consumers from the illicit to the regulated vape market.

    The story also highlights that China remains the dominant supplier of vapes to the U.S., with trade data showing exports worth over $4 billion in 2025, even as companies experiment with partial U.S. production or American-themed branding to adapt to tariffs, enforcement actions, and changing consumer perceptions.